Clinical Trial: Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome

Brief Summary: The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment.

Detailed Summary: The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment. Patients will be implanted with hypothalamic DBS electrodes. Calorimetric and anthropometric measures, body mass index, side effects, neuropsychiatric evaluations will be carried out at 6 months for measuring primary and secondary outcome. Side effects will be monitored at 1, 3, 6 and 12 months following surgery.
Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome:

  • waist circumference; mid−upper arm circumference [ Time Frame: 6 months ]
  • resting energy expenditure [ Time Frame: 6 months ]
  • Body mass index [ Time Frame: 6 months ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • daily food ingestion diary listing [ Time Frame: 6 months ]
  • Child Yale-Brown Obsessive Compulsive Scale [ Time Frame: 6 months ]
  • Child Behaviour Checklist [ Time Frame: 6 months ]
  • Feeding Behaviour Questionnaire [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: October 30, 2014
Date Started: October 2014
Date Completion: October 2016
Last Updated: December 15, 2015
Last Verified: November 2014